EXHIBIT 10.19.1
FIRST AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT (Infigen IP)
This First Amendment to Exclusive License Agreement (Infigen IP) ("First
Amendment") is made and entered into as of this 25th day of August, 2005 (the
"Amendment Effective Date"), by and between Advanced Cell, Inc. (formerly known
as Advanced Cell Technology, Inc.), a Delaware corporation with offices located
at ▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("LICENSOR"), and
Lifeline Cell Technology, LLC (formerly known as PacGen Cellco, LLC), a
California limited liability company with offices located at ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("LICENSEE") (LICENSOR and LICENSEE sometimes
hereinafter referred to individually as a "Party" and collectively as the
"Parties").
WHEREAS, the Parties previously entered into an Exclusive License Agreement
(Infigen IP), dated May 14, 2004 (the "License Agreement"), which grants
LICENSEE defined rights to use certain intellectual property controlled by
LICENSOR; and
WHEREAS, the Parties also entered into that certain Agreement to Amend
ACT/Cellco License Agreements dated September 7, 2004 (the "Agreement to
Amend"), which contemplates that the Parties will amend the License Agreement in
certain respects; and
WHEREAS, the Parties have agreed to amend the License Agreement as provided
herein;
NOW, THEREFORE, in consideration of the premises and terms of this First
Amendment, and in consideration of the payment to LICENSOR by LICENSEE of
$9,375, the receipt of which is hereby acknowledged by LICENSOR, the Parties
agree to amend the License Agreement as follows:
1. Section 1.2 is deleted in its entirety and replaced with the following:
1.2 "FIELD" shall mean the research, development, manufacture and selling
to third parties of human cells for cell therapy in the treatment of
human (a) diabetes, (b) liver diseases and (c) retinal diseases and
retinal degenerative diseases; but FIELD shall exclude applications
involving the use of cells in the treatment of tumors where the
primary use of the cells is the destruction or reduction of tumors and
does not involve regeneration of tissue or organ function.
2. Section 1.3 is deleted in its entirety and replaced with the following:
1.3 "KNOW-HOW" means all compositions of matter, techniques and data and
other know-how and technical inventions (whether or not patentable),
improvements and developments, practices, methods, concepts, trade
secrets, documents, computer data, computer code, apparatus, clinical
and regulatory strategies, test data, analytical and quality control
data, formulation, manufacturing, patent data or descriptions,
development information, drawings, specifications, designs, plans,
proposals and technical data and manuals and all other proprietary
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information that is owned or controlled by LICENSOR as of the
Effective Date that relates to cloning technology or to any of the
subject matter described in or claimed by the PATENT RIGHTS and is
relevant to the FIELD. By way of illustration, but not in limitation,
KNOW-HOW shall include commercial rights in the FIELD to any existing
or potential research products, including reagents, developed by
LICENSOR in the course of its in-house research as more fully
described in Section 15.3 of this Agreement. An example of this is the
proprietary culture medium developed by LICENSOR in the course of the
development of LICENSOR's proprietary ooplasmic transfer technology.
3. Section 1.9 is amended by deleting the text in Section 1.9 in its entirety
and replacing it with the following: "Intentionally omitted".
4. Section 2.5 is deleted in its entirety and replaced with the following:
LICENSEE acknowledges and agrees that notwithstanding anything to the
contrary in this Agreement, LICENSOR may: (i) practice the LICENSED
TECHNOLOGY and develop and manufacture LICENSED PRODUCTS within the
FIELD for research purposes, provided that LICENSOR may not market or
sell LICENSED PRODUCTS in the FIELD to third parties in contravention
of LICENSEE'S exclusive rights hereunder; (ii) distribute or otherwise
transfer cells or cell lines or other reagents to collaborators for
research purposes, and commercialize the results of such research
(other than media and other reagents produced for sale to the
commercial research market) outside the FIELD in connection with the
research, development, manufacture or sale of therapeutic products
that are not in contravention of LICENSEE'S exclusive rights
hereunder; and (iii) distribute or otherwise transfer cells or cell
lines to collaborators for the purposes of researching, developing and
commercializing cell based therapeutics for purposes other than those
exclusively licensed to LICENSEE hereunder.
By way of illustration of subparagraph (ii) of Section 2.5 hereof,
should LICENSOR partner with a biopharmaceutical company in order to
produce skin cells for human therapeutic use, and in the process of
basic research, preclinical, or clinical development find it necessary
or useful to transfer cell lines or other reagents to that partner to
facilitate the development of such dermatological product, such
transfer, provided that the transferred material is not sold or
marketed to such biopharmaceutical company for monetary compensation,
shall be considered outside of the FIELD.
LICENSOR may make LICENSED PRODUCTS available to its collaborators. In
the event LICENSOR requests that LICENSEE deliver to LICENSOR LICENSED
PRODUCTS in the FIELD for use in connection with the purposes
described in the above paragraph, LICENSEE shall make such LICENSED
PRODUCTS available to LICENSOR on commercially reasonable terms.
LICENSOR may make LICENSED
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PRODUCTS in the FIELD, whether developed and manufactured by
LICENSOR or obtained from LICENSEE, available to its collaborators,
provided that LICENSOR enters into a license with any such
collaborator that expressly prohibits the collaborator from
commercializing the LICENSED TECHNOLOGY in the FIELD or using the
LICENSED PRODUCTS in the FIELD for any purpose other than in
connection with the collaboration with LICENSOR for the purposes
described above. LICENSOR shall provide LICENSEE with a copy of any
such license entered into with a collaborator prior to delivering
any LICENSED PRODUCTS in the FIELD; PROVIDED, HOWEVER, that LICENSOR
may redact from such license agreements any financial terms LICENSOR
considers proprietary or confidential and not relevant to LICENSEE'S
exclusive rights hereunder, and PROVIDED FURTHER that any such
licenses provided to LICENSEE shall be considered and treated as
Confidential Information under Article 10 of this Agreement. Any
license by LICENSOR to a collaborator hereunder shall specifically
provide that any intellectual property developed under such
collaboration shall be treated as if developed by LICENSOR for
purposes of determining if it is subject to any of the provisions of
this Agreement.
5. Section 2.6 is deleted in its entirety.
6. Section 4.3 is amended in part by deleting the text (including numbers)
after the words "and the following minimum amounts:" and replacing such
text with the following:
(i) At 12 months, $7,500
(ii) At 24 months, $7,500
(iii) At 36 months, $6,875
(iv) Annually thereafter, $15,000
7. Section 15.3 is amended by deleting the words "including any rights
acquired under Section 15.18 hereof,".
8. Section 15.18 is amended by deleting the text in said Section in its
entirety and replacing it with the following:
15.18 To support the grant of rights hereunder with respect to retinal
disease, LICENSOR shall provide the services of ▇▇▇▇▇▇ ▇▇▇▇▇, M.D.,
his assistants and the use of such lab space and equipment as they
may need that LICENSOR can reasonable supply, understanding that ▇▇.
▇▇▇▇▇, his assistants are the full-time employees of LICENSOR and
the equipment will be primarily used for LICENSOR research. Such
assistance will be for a period of the earlier of one year from the
date of this Amendment or until:
(a) the completion of preliminary animal studies to assess safety
and efficacy of applying cells for the treatment of retinitis
pigmentosa and/or
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macular degeneration (including any contracts or rights
already established for initial animal studies);
(b) completion and submission of a scientific paper to a
peer-reviewed journal co-authored by LICENSOR and LICENSEE
scientists presenting animal data and analysis (subject to the
pre-approval of both parties prior to publication);
(c) completion of consultations with the FDA to assess the
suitability of animal data gathered to initiate the paperwork
for early stage human clinical trials;
(d) initiation of process of filing the paperwork for early stage
human trials.
A committee composed of ▇▇▇▇▇▇▇ ▇▇▇▇, Ph.D., ▇▇▇▇▇▇ ▇▇▇▇▇, M.D. and
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, Ph.D., as the LICENSOR representatives, and
▇▇▇▇▇▇▇ ▇▇▇▇▇ and two additional representatives from LICENSEE that
LICENSEE will promptly identify to LICENSOR in writing (the
"Committee"), will meet periodically during the six-month period
commencing on the Amendment Effective Date to discuss completion of
the above-identified tasks.
The LICENSEE Committee representatives may consult informally with
the LICENSOR Committee representatives, both in person and by
telephone, regarding issues of mutual interest identified by the
Committee. The Committee shall meet during such six-month period at
the facilities of LICENSOR or LICENSEE as shall be mutually
determined; the time and place of such meetings, and the agenda for
such meetings, shall be determined by mutual agreement. It is
contemplated by the Parties that the Committee will meet three times
during the six-month period. Either party may replace its
representatives at any time, upon written notice and mutual
agreement of the parties.
The foregoing notwithstanding, if LICENSOR is unable or unwilling to
complete the tasks outlined in this Section 15.18 above, LICENSEE
shall have the right to manage and carry the work forward so long as
LICENSEE provides funding for the project, in which case any
intellectual property that is developed under LICENSEE's management
and funding shall accrue to LICENSEE, and LICENSEE shall be entitled
to treat as prepayment of future licensing requirements under this
and other license agreements between LICENSOR and LICENSEE the
actual costs incurred by LICENSEE in completing subsections (a)
through (d) above; PROVIDED, HOWEVER, that LICENSEE shall not be
entitled to treat any such costs as prepayment of future licensing
requirements under this and other license agreements between
LICENSOR and LICENSEE if LICENSOR transfers to LICENSEE the
technological protocols, techniques and training necessary for
LICENSEE to replicate LICENSOR'S generation of retinal cells from
stem cells. LICENSEE and LICENSOR agree that the transfer to
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LICENSEE of the technological protocols, techniques and training
necessary for LICENSEE to replicate LICENSOR'S generation of retinal
cells from stem cells shall be complete when LICENSOR provides
LICENSEE with written copies of such protocols and techniques and
two weeks of additional lab training at the Worcester facility by
two qualified technicians within six months after the Amendment
Effective Date.
9. The Agreement is amended by replacing all references to the word "Product"
with the term "Licensed Product".
10. This First Amendment shall be governed by and construed in accordance with
the laws of the State of Delaware, without regard to principles of
conflicts of law thereof, and shall be binding upon and inure to the
benefit of the Parties and their respective successors and assigns.
11. The Parties agree that the Agreement to Amend is terminated by mutual
agreement and that all of its provisions are superseded in their entirety
by this First Amendment. The License Agreement, as amended hereby,
contains the entire agreement of the Parties hereto and thereto with
respect to the matters discussed herein and therein. This First Amendment
may not be modified except in writing signed by the Parties.
12. Except to the extent specifically amended hereby, the terms and provisions
of the License Agreement are hereby ratified and affirmed in all respects
and continue in full force and effect.
IN WITNESS WHEREOF, this First Amendment has been executed by duly
authorized representatives of the Parties as of the Amendment Effective Date.
ADVANCED CELL, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇
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Printed Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇
Title: Chief Executive Officer
LIFELINE CELL TECHNOLOGY, LLC
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
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Printed Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: Managing Member